TR201911986A2 - OSTEOSYNTHESIS/OSTEOINTEGRATION ACCELERATOR MAGNESIUM AND/OR STRONTIUM ADDED COATINGS - Google Patents

Abstract

The Mg and / or Sr doped biocompatible coatings (e.g. TiN) of the invention act as a Mg and / or Sr source and release Mg and / or Sr ions locally from the surface to the fracture line, accelerating osteosynthesis / osteointegration

Description

DESCRIPTION OSTEOSYNTHESIS/OSTEOINTEGRATION ACCELERATOR MAGNESIUM AND/OR STRONTIUM ADDED COATINGS Technical Field The invention relates to making osteosynthesis/osseointegration-promoting Mg (magnesium) or Sr (strontium) releasable on the surfaces of biomaterials through coating and/or surface polishing. The material surfaces of the invention are used to facilitate osteosynthesis and/or osteointegration in the bone area that is damaged or treated. Prior Art In the current art, applications are available to improve the resistance of these fixation (implants and prostheses) systems against corrosion and corrosion by applying corrosion-resistant coatings such as TiN to bone fixation systems used in the treatment of bone fractures. Separately, external implantsEda make various hydroxyapatite coatings to improve the osteointegration of home orthopedic prostheses There are also applications. Among these applications, increasing osteointegration by coating in-vitro synthesized hydroxy apatite on biomaterial surfaces is widely used. Due to its low mechanical strength, hydroxyapatite cannot be used alone and can be applied as a coating on biomaterial surfaces, especially in areas exposed to load. However, in these applications, especially screw applications, it may not work effectively due to the hydroxyapatite on the surface being removed from the surface. Magnesium and its alloys are biocompatible: their use in metabolism and their mechanical properties make them suitable for use in the body. There have been many studies on their use in bone fixation systems. However, magnesium and its alloys also have disadvantages such as low corrosion resistance within the body and gas release as a result of corrosion. This situation limits the use of magnesium alloys as biomaterials. However, magnesium increases the biocompatibility of hydroxyapatite by replacing the Ca in hydroxyapatite, which is a component of bone and tooth structure. In practice, hydroxy apatite is generally used by coating it on intraosseous prosthesis and external screw surfaces for the purpose of improving osteointegration. As mentioned above, in these applications, due to mechanical effects, hydroxy apatite may be removed locally from the surface [reducing the effectiveness of Imas Sila]. In the current system, the bone fixation systems used in the treatment of ashy bone have the function of fixing by bringing the bone tips together. In these fixation systems, oxide coatings are applied to improve corrosion properties. These bone fixation systems have the feature that 3rd generation new bio-materials should have, that is, tissue repair. It does not have the ability to trigger/accelerate. For this reason, the current bone fixation system only serves as a mechanical support that holds the bone ends together and ensures that the bone stays together during its own healing process, but it does not have a positive effect on the healing of the hairline by maintaining osteosynthesis. This situation reveals the need to develop coatings with EE:Mg or Sr additives for osteosynthesis, which is the subject of the invention. In the patent numbered CN105349858A in the current literature on the subject of the patent, the use of alloys containing Mg and Ag is mentioned, but the effect of the existing alloy on osteosynthesis is not mentioned. In another Chinese patent on the subject numbered CN105597160A, Mg alloy is used again and the aim is to improve the mechanical properties of the material and osteosynthesis is not targeted. In the Chinese patent numbered CN 106999284A, a base element made of magnesium or magnesium alloy and a porous anodic oxide coating film formed on the surface of the base element are mentioned in order to increase the hydrophilicity of implant materials. In the patent in question, the porous anodic oxide film coated on magnesium alloy is intended to increase biocompatibility and it is not mentioned that it has an effect on osteosynthesis. In the Chinese patent document numbered CN107119260A found in the current literature, the magnesium-rich coating and preparation method, which has the potential to be used in bone prostheses, is mentioned to solve the osteointegration and infection problems of implant materials. In the French patent document number FR2751201A1, an osteosynthesis implant designed to connect two parts of the skeleton is mentioned. A Mg alloy is mentioned that can be used as a bone substitute or for bone treatment due to its controllable, excellent strength for bone tissue and interface strength. The methods and materials mentioned in the literature summary above are generally aimed at improving bone fixation and osteointegration. The main function of the materials recommended for use in bone fixation systems is to increase mechanical strength and corrosion resistance, and 3rd generation biomaterials have | It does not have the function of being able to trigger the necessary tissue repair and land Hma. Purposes of the InventionL and KLsa Description The purpose of this invention is to create osteosynthesis/osteointegration h&land Ean coating or surfaces by means of Mg (magnesium) or Sr additive 3 El E. For this purpose, a coating approved by the LFDA for use in the body on bio materials that have already been used by EDA. It is aimed to stimulate osteosynthesis by adding Mg and/or Sr to the system (such as TiN). It is also possible to achieve osteointegration with the coatings or surfaces in question. Current Mg alloy m1 applications are faced with corrosion problems and gas release caused by corrosion. Mg and alloy Elarßl are used directly in the body. Accordingly, another aim of this invention is to develop coatings/surfaces that have high corrosion resistance and prevent inflammation problems by using Mg (magnesium) added coatings instead of using direct Mg (magnesium) alloys or surface alloying with low Mg content. The subject of the invention is to realize local Mg and/or Sr release energy from the surface to the hard tissues that are desired to be treated, by acting as a Mg and/or Sr source, with coatings such as TiN, CrN, DLC, which are biocompatible and have high corrosion resistance, and doped with Mg and/or Sr. As a result of this treatment, it is aimed to reduce the treatment period by increasing the osteosynthesis line. However, osteointegration is also increased due to the fact that saline Mg and/or Sr ions trigger the formation of Mg-HAp and/or Sr-HAp on the biomaterial surface in-vivo. For this reason, the coatings defined in the invention also fulfill the function of triggering/accelerating tissue repair that 3rd generation new biomaterials should have. Single or hybrid coating methods can be used to produce Sr and Magnesium doped films and alloyed surfaces. For example, cathodic arc, magnetic field generation, e-beam evaporation, ion injection, laser/e-beam surface abrasion and use them together in the same chamber [[d [g Esystems (hybrid). An important feature of these coatings in terms of application is that they have high hardness. High surface hardness makes implants to be integrated into the bone (such as external implants) easy to screw into the bone. Eacakt E. Distinction of the Invention [KlamasE] Two application examples of the invention in question are given below. Ti6Al4V based plate/screw systems are used in the fixation of bone bone lines. Stla plate/screw systems were tested on New Zealand rabbits in order to determine the contribution of the developed coating on bone repair (osteosynthesis). For this purpose, firstly, the plate/screw systems were coated with the method whose process steps and details are given in Lasag, in a way to obtain Mg-free TiN and TiN thin films containing at most 15% Mg. plate/screw systems are used. Mg-free TiN coatings: set up as control experiments. E. Coating Methods and Names - After placing the samples in the vacuum chamber, the vacuum chamber was reduced to 5 * 10_3 Pa with a diffusion pump, and the sample surfaces were cleaned by keeping the voltage at each stage for 60 seconds with E application. , - Run only titanium cathodes in argon atmosphere for 4 minutes. Use -150 V bias voltage [removed titanium substrate: coated One Mg/Sr target (with 15 A cathode current I) was coated by working for 60 minutes. - During the coating stage, the bias voltage was applied as mm -150 V. - To ensure that the coatings were homogeneous, the samples were placed both around their own axis and from the center of the vacuum chamber. It was rotated through the coating around a passing axis. Analysis studies were carried out for bone regeneration (osteosynthesis) occurring in the lower bone line. For this purpose, hairline X-ray analyzes (Figure 1), micro tomography analyzes (uCT) (Figure 2) and histology analyzes (Figure 3) were performed on E. 6-week-old bone samples. It has been observed that bone repair and compact bone volume are better in the clay lines made with saline, while the amount of cartilage bone is higher in the samples without Mg salt. Ti6Al4V based|_| Plate/screw systems are used to fix bone bone lines and the application steps of the plate/screw system are fixed in healthy bone areas. In order to determine the effect of the developed coating on the establishment of new bonds with the bone tissue (osteointegration), the plate/screw systems were tested on New Zealand rabbits after being coated as given. Screw holes were opened on the femur bones of the rabbits and the plates were fixed through these holes. High bone cell density and increased mineralization in areas where osteointegration is increased provide information about osteointegration. For this purpose, scanning electron microscope (SEM) analysis (Figure 4) and energy-diffused FlithX-Tsif spectroscopy (EDS) (Figure 5) in the areas where the plates/screws come into contact with the bone surfaces. ) and Von Kossa analyzes were carried out on Mg-free TiN coatings: again, they were designed as control experiments. In the SEM, EDS and Von Kossa analyzes performed on the six-week plate/screw samples, it was found that there were more bone cells on the surfaces coated with Mg-containing TiN and mineralization was much higher. It has been seen that. Explanation of the Figures Figure 1 - Plate/screw system and clay line & X-ray image after six weeks of healing Figure 2 - CT images of the clay line obtained from different directions after six weeks of healing. Figure 3 - Histology analysis of the scar line after six weeks of healing. Figure 4 - SEM image obtained from the screw surface with Mg-doped TiN coated material removed from the femur bone at the end of six weeks. Figure 5 - Coated with Mg-additive TiN removed from the femur bone at the end of six weeks. EDS results obtained from the plate surface TR TR

Claims (1)

1.CLAIMS 3 coating materials containing Mg and/or Sr for osteosynthesis/osteointegration. It is a coating material as in claim 1, and the ratio of the total mole amount of Mg and/or Sr additives to the total mole amount of the coating material must be 15% or less. A coating material according to any one of claims 1 or 2, with titanium as the matrix and/or one or more biocompatible metals and/or alloys and/or one or more of the biocompatible nitride, carbide, carbon nitride and oxide forms of metals. What's more, it contains Five/or diamond-like coating (DLC). It is a coating material according to claim 3, and it contains one or more elements selected from the list consisting of said biocompatible metal and/or alloys Titanium, Zirconium, Tantalum and Niobium. TR TR